Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

September 1, 2020 updated by: N. Stuart Harris MD MFA, Massachusetts General Hospital
Trial of Non-Invasive Positive Pressure Ventilation Management of High Altitude Pulmonary Edema

Study Overview

Detailed Description

Patients in the Everest area will assessed for evidence of acute HAPE. Subjects will be randomized and assigned to standard care options or treatment with Non-Invasive Positive Pressure Ventilation.

Study Type

Interventional

Enrollment (Anticipated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Kathmandu, Nepal
        • Recruiting
        • Himalayan Rescue Association
        • Contact:
        • Sub-Investigator:
          • Brian M Strickland, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy adults (age 18-80)
  • Travel through Pheriche, Nepal
  • Diagnosis of HAPE by symptoms, vital signs, and lung ultrasound

Exclusion Criteria:

  • History of chronic respiratory conditions (asthma, COPD, ILD)
  • Concomitant pneumonia or aspiration, cardiomyopathy, congestive heart failure
  • Kidney disease
  • Neurologic disorder
  • Cognitive disorder
  • Temporary altered mental status
  • Use of phosphodiesterase inhibitors or nifedipine prior to diagnosis of HAPE
  • Age under 18 or over 80
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard of Care Treatment
Continuous supplemental oxygen and nifedipine 30mg will be administered to patients.
Nifedipine 30mg, Pharmacotherapy
supplemental oxygen
Experimental: Non-Invasive Positive Pressure Ventilation Management
CPAP at 10mmHg with supplemental oxygen, as well as nifedipine 30mg will be administered to patients.
Nifedipine 30mg, Pharmacotherapy
Continuous positive airway pressure delivered by face mask at 10cmH2O
Other Names:
  • CPAP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxygen saturation
Time Frame: Up to 4 hours
Displayed on pulse oximeter
Up to 4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonographic assessment of pulmonary edema
Time Frame: Up to 4 hours
Quantification of B-lines
Up to 4 hours
Subjective rating of dyspnea
Time Frame: Up to 4 hours
Based on Dypnea Severity Scale (DSS)
Up to 4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2020

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

February 25, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

September 3, 2020

Last Update Submitted That Met QC Criteria

September 1, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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